Bottom Line:
Ten patients (40%) stopped the therapy because of futility rules and 3 (12%) due to adverse events.There were no deaths, while two patients were hospitalized due to side effects.The triple therapy with BOC+pIFN+RBV in this cohort of real-life treatment-experienced CHC G1 patients and advanced liver disease was safe offering cure in the majority of those who could tolerate and complete treatment under a close monitoring.

Background: The aim of our study was to evaluate the safety and efficacy of triple therapy using boceprevir (BOC) with pegylated interferon (pIFN)/ribavirin (RBV) in chronic hepatitis C (CHC) genotype 1 (G1) treatment-experienced patients with advanced fibrosis or compensated cirrhosis.

Methods: We report the Greek experience on the first CHC patients who received BOC-based regimen. From September 2011 to June 2012, 26 treatment-experienced CHC patients and G1 with bridging fibrosis or compensated cirrhosis received 48 weeks of BOC+pIFN+RBV antiviral therapy. Data on complete blood counts and HCV RNA levels were obtained prior to therapy, at treatment weeks 4, 8, 12, 24, 36, 48 and 24 weeks after the end of treatment.

Results: A full set analysis was performed in 25 of 26 patients. Nine patients (36%) achieved sustained viral response (SVR). Ten patients (40%) stopped the therapy because of futility rules and 3 (12%) due to adverse events. Four patients (16%) developed a virological breakthrough (3 of those presented futility rules as well) and 2 (8%) relapse. All patients who achieved SVR had G 1b, 6 (67%) were non-cirrhotic and 5 (55%) had >1 log decline in baseline HCV RNA levels at week 4 of the treatment. There were no deaths, while two patients were hospitalized due to side effects.

Conclusion: The triple therapy with BOC+pIFN+RBV in this cohort of real-life treatment-experienced CHC G1 patients and advanced liver disease was safe offering cure in the majority of those who could tolerate and complete treatment under a close monitoring.

Figure 2: Percentage of patients who did not respond to treatment due to virological breakthrough and relapse or who stopped theraphy due to futility rules

Mentions:
Seven patients (28%) with HCV RNA >100 IU/mL at week 12 and 3 (12%) with detectable HCV RNA at week 24 stopped treatment (futility rules). Four patients (16%) presented a virological breakthrough (3 of those after week 12 who are the same patients with futility rules at week 24 and 1 patient after week 24) and 2 patients (8%) relapsed following end of treatment with detectable HCV RNA levels at week 72 (Fig. 2).

Figure 2: Percentage of patients who did not respond to treatment due to virological breakthrough and relapse or who stopped theraphy due to futility rules

Mentions:
Seven patients (28%) with HCV RNA >100 IU/mL at week 12 and 3 (12%) with detectable HCV RNA at week 24 stopped treatment (futility rules). Four patients (16%) presented a virological breakthrough (3 of those after week 12 who are the same patients with futility rules at week 24 and 1 patient after week 24) and 2 patients (8%) relapsed following end of treatment with detectable HCV RNA levels at week 72 (Fig. 2).

Bottom Line:
Ten patients (40%) stopped the therapy because of futility rules and 3 (12%) due to adverse events.There were no deaths, while two patients were hospitalized due to side effects.The triple therapy with BOC+pIFN+RBV in this cohort of real-life treatment-experienced CHC G1 patients and advanced liver disease was safe offering cure in the majority of those who could tolerate and complete treatment under a close monitoring.

Background: The aim of our study was to evaluate the safety and efficacy of triple therapy using boceprevir (BOC) with pegylated interferon (pIFN)/ribavirin (RBV) in chronic hepatitis C (CHC) genotype 1 (G1) treatment-experienced patients with advanced fibrosis or compensated cirrhosis.

Methods: We report the Greek experience on the first CHC patients who received BOC-based regimen. From September 2011 to June 2012, 26 treatment-experienced CHC patients and G1 with bridging fibrosis or compensated cirrhosis received 48 weeks of BOC+pIFN+RBV antiviral therapy. Data on complete blood counts and HCV RNA levels were obtained prior to therapy, at treatment weeks 4, 8, 12, 24, 36, 48 and 24 weeks after the end of treatment.

Results: A full set analysis was performed in 25 of 26 patients. Nine patients (36%) achieved sustained viral response (SVR). Ten patients (40%) stopped the therapy because of futility rules and 3 (12%) due to adverse events. Four patients (16%) developed a virological breakthrough (3 of those presented futility rules as well) and 2 (8%) relapse. All patients who achieved SVR had G 1b, 6 (67%) were non-cirrhotic and 5 (55%) had >1 log decline in baseline HCV RNA levels at week 4 of the treatment. There were no deaths, while two patients were hospitalized due to side effects.

Conclusion: The triple therapy with BOC+pIFN+RBV in this cohort of real-life treatment-experienced CHC G1 patients and advanced liver disease was safe offering cure in the majority of those who could tolerate and complete treatment under a close monitoring.